High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- 68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2.
研究概览
简要总结
This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.
详细描述
Novel, sensitive tools, such as 68Ga-PSMA PET imaging, have great potential for very early disease detection and open the possibility of early curative local salvage treatment (with surgery, radiotherapy or a combination of both). This project will moreover provide important insights into the biodistribution and dosimetry of 68Ga-PSMA, opening possibilities of 90-Yttrium or 177-Lutetium-PSMA-based radionuclidetherapy of patients with metastatic PC in the future.
The study consists of 2 work units (WU):
Work-unit 1: Patients at high risk for nodal involvement prior to radical prostatectomy with extended lymph node dissection Work-unit 2: Biochemical recurrence after initial treatment with curative intent
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Work-unit 1
- •age < 75 years of age, with histologically proven invasive adenocarcinoma of the prostate
- •a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1)
- •scheduled to undergo radical prostatectomy with extended lymph node dissection
- •Work-unit 2
- •histologically proven diagnosis of prostate cancer
- •biochemical relapse (two consecutive PSA≥0.2 ng/ml) of prostate cancer following radical local prostate treatment
- •WHO performance state 0-1
- •age > 18 years old
排除标准
- •Work-unit 1
- •involvement of pelvic lymph nodes assessed by multi-parametric MRI
- •evidence for bone metastasis assessed by bone scan (if PSA > 20 ng/ml)
- •WHO performance status > 2
- •previous pelvic irradiation or radical prostatectomy.
- •other malignancy except adequately treated basal cell carcinoma of the skin diagnosed during the last 5 years
- •any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •Work-unit 2
- •serum testosterone level <50ng/ml
- •symptomatic metastases
- •local relapse on MRI
- •PSA rise while on active treatment with LHRH-agonist, LHRH-antagonist, Anti-androgen, Complete androgen blockade, Oestrogen-antioestrogen therapy
- •previous treatment with cytotoxic agent for PCa
- •treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)
- •disorder precluding understanding of trial information or informed consent
研究组 & 干预措施
68Ga-PSMA PET/MR
Hybrid 68Ga-PSMA PET/MR scan
干预措施: 68Ga-PSMA (HBED-CC) PET (Other)
结局指标
主要结局
68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2.
时间窗: through study completion, an average of 2 year
Assessment of the sensitivity, specificity, positive and negative predictive
次要结局
- The evaluation of change in patient management based on imaging results of 68Ga-PSMA PET/MR in patients with biochemical recurrence. Work unit 2.(through study completion, an average of 2 year)
- The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1.(through study completion, an average of 2 year)
- Comparison of diagnostic accuracy between 68Ga-PSMA PET, MR and combined 68Ga-PSMA PET/MR. Work unit 2.(through study completion, an average of 2 year)